Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis (TEA in SSc)

November 30, 2023 updated by: Zsuzsanna Hortobagyi Mcmahan, The University of Texas Health Science Center, Houston
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients with SSc-constipation from Aim 1 of the study
  • Patients with SCT (>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
  • Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Exclusion Criteria

-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Electrical Acustimulation (TEA)
Device: Transcutaneous Electrical Acustimulation (TEA)
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham Comparator: Sham-TEA
Device: Sham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in slow colonic transit (SCT)
Time Frame: baseline, week 4 (visit 2)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
baseline, week 4 (visit 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in rectal hyposensitivity as assessed by the anorectal manometry
Time Frame: baseline, week 4 (visit 2)
baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Time Frame: baseline, week 4 (visit 2)
baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
Time Frame: baseline, week 4 (visit 2)
This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
Time Frame: baseline, week 4 (visit 2)
baseline, week 4 (visit 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Zsuzsanna H McMahan, MD, MHS (M-PI), The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2024

Primary Completion (Estimated)

August 14, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-23-0531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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